Cleared Traditional

ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 (K961777) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961777 · Cardio Metrics, Inc. · Cardiovascular device
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Jul 1996
Decision
85d
Days
Class 2
Risk

K961777 is an FDA 510(k) clearance for the ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cardio Metrics, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 31, 1996 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardio Metrics, Inc. devices

Submission Details

510(k) Number K961777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1996
Decision Date July 31, 1996
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 228
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K961777.
CORDIS ST STEERABLE GUIDEWIRE
K963214 · Cordis Corp. · Nov 1996
CINCH QR SGW EXTENSION
K963171 · Cordis Corp. · Nov 1996
CORDIS STABILIZER PLUS XS
K962932 · Cordis Corp. · Oct 1996
USCI COMMANDER SERIES GUIDE WIRES
K961271 · C.R. Bard, Inc. · Jun 1996
CORDIS WIZDOM STEERABLE GUIDEWIRE
K953760 · Cordis Corp. · Nov 1995
PRECEDER GUIDEWIRE
K953023 · Boston Scientific Corp · Sep 1995